FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Lingo Glucose System
K Number: K233655
·
Decision May 29, 2024
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
3
Applicant Total
12
Review Days
197
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Basic Information
- Device Name
- Lingo Glucose System
- K Number
- K233655
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1355
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott
- Date Received
- November 14, 2023
- Decision Date
- May 29, 2024
- Product Code
- SAF
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SAF | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (SAF), ordered by most recent decision date.
Stelo Glucose Biosensor System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Signos Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Stelo Glucose Biosensor System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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